FDA Enforcement
Class II
Terminated
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Recall: Z-0966-2019
·
Reported March 6, 2019
Enforcement
- Recall Number
- Z-0966-2019
- Event ID
- 82019
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2019
- Initiation Date
- December 20, 2018
- Classification Date
- February 27, 2019
- Termination Date
- August 20, 2019
- Address
- 125 Blue Ball Rd, Elkton, MD, 21921-5315, United States
Description
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Reason
Presence of natural rubber latex is not declared in the label
Code Info
Lot Numbers: V A30
Distribution
TX
Quantity
12 packs